A Nutritional Intervention for Migraines-2 (WCCR-MIG2)

The purpose of the study is to assess whether, in individuals with migraines, a low-fat, vegan diet improves pain more effectively than a control supplement or a placebo. The principal measures are pain as measured by Visual Analog Scale (VAS) and the change in migraines frequency. The study duration is 36 weeks.This study also tests that a low fat, plant-based (vegan) diet free of foods commonly identified as triggers improves mood, using the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II).

Study Overview

• Status: Completed
• Conditions: Migraines
• Intervention / Treatment: Other: Plant based diet; Other: an unrestricted diet

Detailed Description

Preliminary evidence suggests that low-fat, vegetarian diets and certain nutritional supplements can help reduce pain and also reduce the need for pain medications for some people. The investigators will ask about 100 people to participate. All of them will get a low-fat, vegan diet and a nutritional supplement (mixture of omega-3 oils and vitamin E or a placebo), although some will get the diet first, and others will get the supplement first. This order in which they will get the diet and the supplement will be determined randomly, that is, by chance (like the toss of a coin). The principal measures are pain as measured by Visual Analog Scale (VAS)and the change in migraines frequency.

Mood change will be measured using the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R), and the Beck Depression Inventory II (BDI-II).

• Study Type: Interventional
• Enrollment (Actual): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20016
      • Physicians Committee for Responsible Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

A diagnosis of migraine, as defined by the criteria of the second edition of the International Classification of Headache Disorders:

At least 5 attacks fulfilling criteria the criteria below:

• Headache attacks lasting 4-72 hours (untreated or unsuccessfully treated)
• Headache has at least two of the following characteristics:
• unilateral location
• pulsating quality
• moderate or severe pain intensity
• aggravation by or causing avoidance of routine physical activity (eg, walking or climbing stairs)
• During headache at least one of the following:
• nausea and/or vomiting
• photophobia and phonophobia Not attributed to another disorder
• Migraines occurring at least twice per month, on average.
• Age at least 18 years
• Ability and willingness to participate in all components of the study
• Willingness to be assigned to either the diet group or supplement group
• Migraine medications unchanged within last 6 weeks.

Exclusion Criteria:

• < 18 years of age
• Alcohol consumption of more than 2 drinks per day or the equivalent, episodic increased drinking (e.g., more than 2 drinks per day on weekends), or a history of alcohol abuse or dependency followed by any current use
• Use of recreational drugs in the past 6 months (past drug use, if fully recovered, is not a criteria for exclusion)
• Pregnancy
• Unstable medical or psychiatric illness
• Likely to be disruptive in group sessions (as determined by research staff)
• Already following a low-fat, vegan diet
• Lack of English fluency
• Inability to maintain current medication regimen
• Inability or unwillingness to participate in all components of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Vegan diet; The diet group will be asked to follow a low-fat, vegan diet for 16 weeks.	Other: Plant based diet
Placebo Comparator: Supplement group; The supplement group will follow an unrestricted diet, but will be given a pill containing a small, clinically insignificant amount of omega- 3 oils and vitamin E, which will serve as a placebo.	Other: an unrestricted diet

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Migraines Pain Change in Migraines frequency	Pain as measured by VAS score	Baseline and 4 months
Change in Migraines frequency	the reduction in the number of migraine attacks.	Baseline and 4 months
Improvement in Mood	mood changes will be measured using the Beck Depression Inventory II (BDI-II).	Baseline and 4 months
Improvement in Mood	Mood changes will be measured using the Center for Epidemiologic Studies Depression Scale-Revised (CESD-R).	Baseline and 4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Health related quality of life as measured by a questionnaire	Baseline and 4 months

Collaborators and Investigators

• Sponsor: Physicians Committee for Responsible Medicine
• Investigators: Principal Investigator: Neal Barnard, MD, Physicians Committee for Responsible Medicine

Publications and helpful links

General Publications

• Bunner AE, Agarwal U, Gonzales JF, Valente F, Barnard ND. Nutrition intervention for migraine: a randomized crossover trial. J Headache Pain. 2014 Oct 23;15(1):69. doi: 10.1186/1129-2377-15-69.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: October 1, 2012
• First Submitted That Met QC Criteria: October 2, 2012
• First Posted (Estimate): October 3, 2012

Study Record Updates

• Last Update Posted (Estimate): October 20, 2015
• Last Update Submitted That Met QC Criteria: October 19, 2015
• Last Verified: May 1, 2014

More Information

Terms related to this study

• Keywords: Migraines, diet, vegan, vegetarian, plant-based
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders, Primary; Headache Disorders; Migraine Disorders
• Other Study ID Numbers: WCCR-MIG2